Quality Assurance Engineer

BPI Labs, LLC; Largo (FL); On-site; USD 60,000 - 75,000; Full time

Benefits offered by this job

401(k)

Health insurance

Paid time off

Vision insurance

Job summary

BPI Labs, LLC is seeking a motivated Quality Assurance Engineer to ensure high quality in processes and products. Responsibilities include auditing cGMP documents, leading internal audits, and maintaining CAPA databases.

The ideal candidate will have excellent communication skills, understanding of quality regulations, and at least one year of relevant experience in the pharmaceutical industry.

This position is vital for continuous improvement and customer satisfaction in Largo, FL.

Qualifications

• Minimum one year of experience in pharmaceutical quality activities.
• Excellent verbal and written communication skills are necessary.
• Understanding of 21 CFR Parts 210, 211, and 820.

Responsibilities

• Support the review and auditing of cGMP documents.
• Lead internal audits for the company.
• Maintain corrective and preventative action database.

Skills

Verbal and written communication skills

Computer and documentation skills

Understanding of cGMP practices

Education

Bachelor of Science in Engineering

Job description

Overview

Join a team that’s driving innovation, integrity, and impact across the pharmaceutical industry.

Quality Assurance Engineer

Job Summary

We are seeking a highly motivated and detail-oriented Quality Assurance (QA) Engineer to join our dynamic team. In this role, you will be instrumental in ensuring the highest quality level of the company processes and products, collaborating in the review and auditing of cGMP documents, coordination of corrective and preventative actions as well as deviations and investigations. In addition, the QA Engineer will be handling quality activities such as collaborating with internal and external audits, root cause analysis, trending of quality systems, and CAPA effectiveness.

Responsibilities

• Support the review and auditing of cGMP documents, including manufacturing, laboratory, and facility records.
• Define internal audit plan for the year.
• Lead internal audits for the company according to the established plan.
• Report to management on internal audit findings.
• Perform follow-up to corrective actions derived from internal audits and report status to management.
• Provide input related to internal audits, change requests, non-conformance reports, planned deviations, OOS investigations, CAPA, etc., for Annual Product Reviews.
• Support root cause evaluation as part of non-conformances and writing the respective investigations.
• Support the coordination of the CAPA Program, including its effectiveness evaluation.
• Support in the appropriate closure of investigations and deviations.
• Maintain corrective and preventative action database, ensuring follow-up and proper and timely closures of CAPAs.
• Support in the coordination of Quality Review Board Meeting as well as Management Review Meeting.
• Support in the performance of trending of quality systems, via evaluation of statistical data.
• Support the continuous improvement program.
• Attend training scheduled for every new or revised SOP related to the department's function.
• Assure accomplishment of the training program.
• Provide excellent service and ensure customer satisfaction, eliminating complaints from internal and external customers.
• Comply with any other function assigned by management.

Qualifications

• Excellent verbal and written communication skills.
• Outstanding computer, documentation, and administrative skills.
• Understanding of 21 CFR Parts 210, 211, and 820.
• Understanding of cGMP practices and regulations.
• 401(k)
• Health insurance
• Paid time off
• Vision insurance

Education

• Bachelor of Science in Engineering (i.e. Chemical, Industrial or related field)

Experience

• Minimum one year of experience in the pharmaceutical industry in quality activities such as internal audits, external audits, corrective and preventative actions, handling of deviations and investigations, root cause analysis, trending of quality systems, and CAPA effectiveness.

Work Location: Largo, FL